FDA Action Alert: Vanda, Basilea and J&J/Legend

After a hectic month, the FDA’s calendar appears to be easing up a bit. In the next two weeks, the regulator is facing just three major target action dates, including one potential CAR-T therapy approval that could push the class into earlier lines of treatment for...

FDA Grants Fast Track Designation to LB-P8 for Treatment of PSC

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LB-P8, LISCure Biosciences’ investigational drug for the treatment of primary sclerosing cholangitis (PSC), a rare, chronic, cholestatic liver disease with significant unmet...